Label: HAND SANITIZER APPLE TART SCENTED- alcohol gel

  • NDC Code(s): 56136-062-01
  • Packager: Ganzhou Olivee Cosmetic Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 21, 2020

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  • Drug Facts

  • Active ingredient

    Alcohol   62% 

  • Purpose

     Antiseptic

  • USE

    Decrease bacteria on hands

  • WARNINGS

    For external use only.

    Flammable- Keep produt away from fire or flame.

    When using this product Avoid contact with eyes; in case of contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops and persists

    Warning - Choking Hazard

    Small parts. Not for children under 3 years.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Wet hands thoroughly with product and allow to dry

  • Inactive ingredients

    Water (Aqua), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum). may contain: D&C Red No. 33 (Cl 17200), FD&C Red No. 4 (Cl 14700), FD & C Yellow No. 5 (Cl 19140), FD&C Blue No. 1 (Cl 42090).

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER APPLE TART SCENTED 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-062
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    May containFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    May containFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56136-062-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product07/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/21/2020
    Labeler - Ganzhou Olivee Cosmetic Co., Ltd. (543008195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ganzhou Olivee Cosmetic Co., Ltd.543008195manufacture(56136-062)
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